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Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men

2021年2月15日 更新者：University of Kansas Medical Center
The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).

Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT:

  1. Staying Strong & Healthy Intervention + Usual Care
  2. Usual Care

All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong & Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.

研究类型

介入性

注册 (实际的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90095
        • University of California, Los Angeles
    • Kansas
      • Kansas City、Kansas、美国、66160
        • University of Kansas Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Diagnosed with prostate cancer
  • Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
  • Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
  • Able to speak and read in English or Spanish
  • Reachable consistently by telephone
  • Able to travel to KUMC

Exclusion Criteria:

  • Not diagnosed with prostate cancer
  • Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
  • Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
  • Not able to speak and read in English or Spanish
  • Not reachable consistently by telephone
  • Not able to travel to the study site for data collection

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Staying Strong & Healthy Intervention (SS&H)
Participants will take part in a 6-month exercise program and diet and nutrition coaching program. Also part of this arm is a nutritional and lifestyle counseling program to be lead by a member of the study team. Participants will also receive the usual care they would normally receive if not taking part in this study.
行为的：Exercise Program
Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.
行为的：Diet and Nutrition Coaching
Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.
其他：Usual Care with Attention
Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.
有源比较器：Usual Care with Attention (UCA)
Participants will receive the usual care they would normally receive if not taking part in this study.
其他：Usual Care with Attention
Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change in LDL
大体时间：Change from Baseline to Month 12
Change from Baseline to Month 12

次要结果测量

结果测量
措施说明
大体时间
Change in Body Mass Index (BMI)
大体时间：Change from Baseline to Month 6
Change from Baseline to Month 6
Change in Body Mass Index (BMI)
大体时间：Change from Baseline to Month 12
Change from Baseline to Month 12
Change in Lipid Profile
大体时间：Change from Baseline to Month 6
Change from Baseline to Month 6
Change in Lipid Profile
大体时间：Change from Baseline to Month 12
Change from Baseline to Month 12
Change in Waist/Hip Circumference
大体时间：Change from Baseline to Month 6
Change from Baseline to Month 6
Change in Waist/Hip Circumference
大体时间：Change from Baseline to Month 12
Change from Baseline to Month 12
Change in Glucose
大体时间：Change from Baseline to Month 6
Change from Baseline to Month 6
Change in Glucose
大体时间：Change from Baseline to Month 12
Change from Baseline to Month 12
Change in Health Related Quality
大体时间：Change from Baseline to Month 6
Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.
Change from Baseline to Month 6
Change in Health Related Quality
大体时间：Change from Baseline to Month 12
Quality of life will be measured using the SF-12 and Expanded Prostate Cancer Index Composite. The two are scored together and result in a composite score. Scores can range from 0-100. The higher the score the better the quality of life.
Change from Baseline to Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Kansas Medical Center

合作者

National Institute of Nursing Research (NINR)

调查人员

  • 首席研究员：Sally Maliski, PhD, RN, FAAN、University of Kansas Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年3月7日

初级完成 (实际的)

2020年7月1日

研究完成 (实际的)

2020年7月31日

研究注册日期

首次提交

2016年11月17日

首先提交符合 QC 标准的

2016年11月17日

首次发布 (估计)

2016年11月21日

研究记录更新

最后更新发布 (实际的)

2021年2月17日

上次提交的符合 QC 标准的更新

2021年2月15日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00004205
  • R01NR014518 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Exercise Program的临床试验

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医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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